30 Pump, Continuous Low Flow, 200 Pump, Intermittent with Kvo or Continuous, Pca Pump, Pain Management, Pcea Pump, Epidu

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K991363 ↗

FDA Product Code

FRN

Device Class

Class II

Regulation

21 CFR Part 880.5725

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Ambit Continuous Ambulatory Infusion Pump

  Class II

  FDA 510(k) K033325 Active Cleared 6 Nov 2003

• Empty Reservoir Bag, 50 Ml, 100 Ml, 250 Ml, 500 Ml, 1000M Ml, 1500 Ml, 2000 Ml, 3000 Ml

  Class II

  FDA 510(k) K001287 Active Cleared 9 Jun 2000

• Palm Pump

  Class II

  FDA 510(k) K002434 Active Cleared 23 Aug 2000

• Ambit Intermittent Ambulatory Infusion Pump

  Class II

  FDA 510(k) K033425 Active Cleared 6 Nov 2003

• Ambit Push & Play Ambulatory Infusion Pump

  Class II

  FDA 510(k) K052221 Active Cleared 8 Dec 2005